MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT

Model Number TYY-NNNNM

Device Problem Installation-Related Problem (2965)

Patient Problem Joint Disorder (2373)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

This patient was a post-trauma/ankyloses patient who was scheduled to receive bilateral tmj implants on (b)(6) 2019.On (b)(6) 2019, the surgeon was unable to release the ankylosis and rotate the patient's mandible as planned.The surgeon indicated that there was significant contracture and ossification of the masseter muscle.The surgeon placed the fossa components bilaterally but could not place the mandibular components due to his inability to mobilize the mandible into the planned position.A ct was taken on (b)(6) 2019, and it showed that the fossa components were not seated in a stable position and that the poly bearing surfaces were not in their designed orientations.The surgeon plans on placing revision components at a later date.

Event Description

The surgeon was unable to get the bilateral mandibular components into their intended positions during surgery.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Type of Device: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer Contact: gregory rose ; 2233 knoll drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 8528201
• MDR Text Key: 142381789
• Report Number: 2031049-2019-00015
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W48447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W48447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR